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Medical Sciences Director - Late Development, Sotorasib

Amgen
Amgen
5+ years
Not Disclosed
10 Nov. 4, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Medical Sciences Director – Late Development, Sotorasib

Job ID:

R-223884

Location:

United States – Remote

Work Location Type:

Remote

Date Posted:

September 09, 2025

Category:

Clinical Development

Salary Range:

$211,263.00 – $251,166.00 USD (Annual)


About Amgen

Amgen is a global biotechnology leader focused on serving patients with serious illnesses. Since 1980, Amgen has pioneered innovative therapies across Oncology, Inflammation, General Medicine, and Rare Disease, impacting millions of patients each year. The company’s culture emphasizes collaboration, scientific excellence, and innovation, offering professionals opportunities to make meaningful contributions to healthcare and patient lives.


Position Summary

As a Medical Sciences Director – Late Development (Sotorasib), you will play a key role in late-phase oncology clinical development. This role involves collaborating with cross-functional teams to design, execute, and interpret late-phase clinical trials and translational studies supporting Amgen’s oncology pipeline.


Key Responsibilities

  • Serve as an internal clinical expert in translational and clinical oncology.

  • Collaborate with the Medical Monitor to support clinical trial-level activities.

  • Participate in strategy development, study design, and execution of late-phase clinical studies.

  • Provide guidance in identifying and managing external partners such as CROs, collaborators, and consultants.

  • Contribute to the development and governance approval of study protocols and clinical plans.

  • Conduct clinical data review, quality checks, and interpretation to ensure regulatory compliance.

  • Present findings to cross-functional teams and leadership; manage scientific and operational issues proactively.

  • Support regulatory submissions, including writing clinical responses and contributing to publications.

  • Utilize data analysis tools (e.g., Spotfire) to evaluate clinical trial data and ensure data integrity.


Basic Qualifications

  • Doctorate degree and 4 years of life sciences/healthcare experience
    OR

  • Master’s degree and 7 years of life sciences/healthcare experience
    OR

  • Bachelor’s degree and 9 years of life sciences/healthcare experience


Preferred Qualifications

  • 5+ years of pharmaceutical clinical drug development experience.

  • Demonstrated expertise in oncology clinical trials (especially late-phase).

  • Strong understanding of GCP standards and regulatory requirements.

  • Experience with clinical data analysis and study data readout processes.

  • Proven record of scientific communication (presentations, publications, or regulatory interactions).

  • Familiarity with data visualization tools such as Spotfire.

  • Experience with cross-functional leadership and process improvement initiatives.


Rewards and Benefits

Amgen offers a comprehensive Total Rewards Plan, including:

  • Competitive base salary and annual performance-based bonuses.

  • Stock-based long-term incentives.

  • Retirement and Savings Plan with company contributions.

  • Comprehensive medical, dental, and vision insurance.

  • Life and disability insurance, and flexible spending accounts.

  • Award-winning time-off and flexible work arrangements (remote/hybrid).

  • Continuous learning and career development resources.


Additional Information

  • Application Deadline: No fixed deadline; open until filled.

  • Equal Opportunity: Amgen is committed to diversity, inclusion, and providing reasonable accommodations for individuals with disabilities.

Apply Now: careers.amgen.com